Cerebrovascular Accident
Conditions
Keywords
rehabilitation, hemiplegic gait, exercise therapy, physical therapy
Brief summary
The purpose of this study is to determine if treadmill training with body weight-support (BWST) is more effective at improving walking in individuals post-stroke than a resisted leg-cycling exercise program. In addition, we want to determine if training programs that combine leg strength training to treadmill walking provide an additional benefit to post-stroke walking outcomes.
Detailed description
Impaired walking ability is a hallmark residual deficit that contributes to post-stroke walking disability . Impairment in lower extremity muscle strength is a significant contributor to decreased walking speed after stroke. No studies have combined task-specific locomotor training in combination with lower extremity strength training programs designed to improve post-stroke walking outcomes. Participants will include individuals who are ambulatory, but walk slower than 1.0 m/sec and are at least 6 months post unilateral stroke. Participants are stratified by initial comfortable walking speed (moderate \>0.5 m/sec; severe \<= 0.5 m/sec) and randomized to one of four exercise pairs: 1) body-weight supported treadmill training (BWST) and locomotor-based strength training (resistive cycling task, LBST), 2) BWST and LE muscle-specific strength training (MSST), 3) BWST and upper extremity ergometry (SHAM), and 4) LBST and SHAM. Training will occur 4 times per week for 6 weeks (24 total sessions). Exercise type in each exercise pair is alternated daily. Primary outcomes include comfortable and fast overground walking speed, and distance walked in 6-minutes measured at baseline, after 12 and 24 treatment sessions and at a 6-month follow-up.
Interventions
PROCEDUREexercise therapy
PROCEDUREwalking rehabilitation
Sponsors
Physical Therapy Clinical Research Network
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or older * 4 months to 5 years after first-time onset of a ischemic or hemorrhagic cerebrovascular accident (CVA) confirmed by CT, MRI, or clinical criteria * able to ambulate at least 14 meters with assistive and/or orthotic device and one person assist (minimum Functional Ambulation Classification Level II * self-selected walking velocity of ≤1.0 meters/second * approval of primary care physician to participate.
Exclusion criteria
* resting systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 110mmHg and/or resting heart rate greater than 100 beats/minute; * lower limb orthopedic conditions such as prior joint replacement or range of motion limitations; * spasticity management that included Botox injection (\< 4 months earlier) or phenol block injection (\< 12 months earlier) to affected lower extremity and intrathecal Baclofen or oral Baclofen (within past 30 days); * Mini-Mental State Exam score \< 24; * currently receiving lower extremity strengthening exercises or gait training, * past participation in any study examining the effects of long term (\>4 weeks training) body weight support treadmill training; limb loaded pedaling, or lower extremity strengthening; * plans to move out of the area in the next year, * no transportation to the study site for all evaluations and intervention sessions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| walking speed (meters/second) | — |
| walking distance (distance walked in 6-minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lower extremity torque | — |
| Lower extremity Fugl-Meyer | — |
| SF-36 | — |
| Stroke Impact Scale | — |
| Berg Balance Score | — |
Countries
United States
Outcome results
None listed